Recruiting

Prolonged Exposure Therapy

Sponsor:

University of Vermont

Code:

NCT06288711

Conditions

Opioid Use Disorder

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prolonged exposure therapy

Financial incentives

Treatment as usual

Study Details

Brief summary:

Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD.

Conditions

Opioid Use Disorder

Posttraumatic Stress Disorder

Study ID

NCT06288711

Start date

Jun 3, 2024

Status verified date

May, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • >18 years old
  • Maintained on a stable methadone or buprenorphine dose for >1 month prior to the study
  • Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5
  • Participants receiving psychotropic medications must be maintained on a stable dose for >1 month prior to enrollment.

Exclusion Criteria:

  • Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview
  • Cognitive impairment as evidenced by scores <22 on the Videoconference-based Mini Mental Status Examination (MMSE; Folstein, et al., 1975)
  • Enrolled in another ongoing evidence-based treatment for PTSD.
  • Pregnancy as verified by pregnancy test
  • No access to cellular service

Study Design

Enrollment

135 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Treatment as usual (TAU)

Participants randomized to TAU will continue to receive standard buprenorphine or methadone maintenance treatment from their current treatment provider and complete follow-up assessments as described above. However, they will not receive posttraumatic stress disorder treatment. Staff will mail participants an emergency naloxone kit containing two naloxone doses with simple instructions, a list of resources and contact information for mental health providers and other relevant resources in their community and assistance contacting any resources of interest.

experimental: Prolonged exposure therapy (PE)

In addition to receiving standard buprenorphine- or methadone-maintenance treatment from their current provider and completing scheduled assessments as described above, PE participants will also receive 12 individual sessions of prolonged exposure therapy scheduled weekly over the 12-week treatment period and delivered via a secure and university-supported telemedicine platform. Beginning in study week 1, PE participants will complete weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by doctoral or master's level therapists trained in prolonged exposure therapy.

experimental: Prolonged exposure therapy + attendance contingent financial incentives (PE+)

Participants assigned to the PE+ condition will receive the procedures noted above for the PE group plus financial incentives delivered contingent upon completion of PE sessions.

Interventions

Prolonged exposure therapy

Twelve weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by therapists trained in prolonged exposure therapy.

Financial incentives

Financial incentives contingent upon completion of prolonged exposure therapy sessions

Treatment as usual

Continued standard buprenorphine or methadone maintenance treatment from current treatment provider.

Primary outcome measure

  • Prolonged exposure therapy session attendance [ Time Frame: From baseline to week 12 ]
  • Prolonged exposure therapy completion [ Time Frame: From baseline to week 12 ]
  • Change in posttraumatic stress disorder symptom severity - clinician rated [ Time Frame: From baseline to week 12 ]

Central Contacts and Locations

Central contacts

Kelly Peck, Ph.D.

8026569610Kelly.Peck@uvm.edu

Locations

University of Vemont

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Kelly R Peck, Ph.D.

8026569610Kelly.Peck@uvm.edu

More Information

Sponsor

University of Vermont

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2026-05-18.